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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

DEA Scheduling Reform Bill Moves Forward in House

The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly.

Background

While a drug is required to be approved by the US Food and Drug Administration (FDA) in order to be marketed, the DEA must also sign off on drugs subject to the Controlled Substances Act (CSA).

The CSA, which provides for the scheduling of drugs into various classes of control, is meant to ensure that drugs that might be misused or abused aren't as readily available to consumers. For example, a drug subject to Schedule II controls might have restrictions on how many refills are available without a new prescription, and the quantity of product allowed to be prescribed at a single time.

The problem, as Focus has noted, is that DEA can take more than a year to schedule a product under the CSA, even when FDA has made specific recommendations regarding the drugs' scheduling. That delay leaves patients without access to an FDA-approved therapy and companies without the ability to market their drug.

The Legislation

On 12 February 2014, the House Energy and Commerce Committee approved the Improving Regulatory Transparency for New Medical Therapies Act.

The legislation also makes it easier to provide drugs under a clinical trial. DEA would be required to review applications to manufacture a controlled substance (Schedule III, IV or V) for use in a clinical trial within 180 days of receiving the application, and Schedule I or II drugs within 180 days, not including a notice and comment period and a 90-day application window.